Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016540', 'term': 'Smoking Cessation'}], 'ancestors': [{'id': 'D015438', 'term': 'Health Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D009538', 'term': 'Nicotine'}], 'ancestors': [{'id': 'D012991', 'term': 'Solanaceous Alkaloids'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D011725', 'term': 'Pyridines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'phone': '866-435-7343', 'title': 'GSK Response Center', 'organization': 'GlaxoSmithKline'}, 'certainAgreement': {'otherDetails': 'GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'AEs were collected from the start of the sequestration period upto 5 days after the last treament', 'eventGroups': [{'id': 'EG000', 'title': 'Nicotine Mouth Film 2.5 mg', 'description': 'Participants received a single dose of 2.5 mg nicotine mouth film placed on the top of tongue and pressed to the roof of mouth until film dissolved (approximately 2 to 3 minutes).', 'otherNumAtRisk': 161, 'otherNumAffected': 6, 'seriousNumAtRisk': 161, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Nicotine Lozenge 2 mg', 'description': 'Participants received a single dose of 2 mg nicotine lozenge to be placed into the mouth and periodically moved from one side of mouth to other, without swallowing until lozenge dissolved (approximately 20 to 30 minutes).', 'otherNumAtRisk': 160, 'otherNumAffected': 29, 'seriousNumAtRisk': 160, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 161, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 160, 'numEvents': 14, 'numAffected': 14}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Epigastric Discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 161, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 160, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Throat Irritation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 161, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 160, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hiccups', 'stats': [{'groupId': 'EG000', 'numAtRisk': 161, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 160, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 161, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 160, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Abdominal Discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 161, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 160, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Abdominal Pain Upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 161, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 160, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 161, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 160, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Gastroesophageal Reflux Disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 161, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 160, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 161, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 160, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Flushing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 161, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 160, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '1'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'The Change From Pre-dose Post-provocation in Craving Score at 50 Seconds', 'denoms': [{'units': 'Participants', 'counts': [{'value': '161', 'groupId': 'OG000'}, {'value': '160', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Nicotine Mouth Film 2.5 mg', 'description': 'Participants received a single dose of 2.5 mg nicotine mouth film placed on the top of tongue and pressed to the roof of mouth until film dissolved (approximately 2 to 3 minutes).'}, {'id': 'OG001', 'title': 'Nicotine Lozenge 2 mg', 'description': 'Participants received a single dose of 2 mg nicotine lozenge to be placed into the mouth and periodically moved from one side of mouth to other, without swallowing until lozenge dissolved (approximately 20 - 30 minutes)'}], 'classes': [{'categories': [{'measurements': [{'value': '-14.15', 'groupId': 'OG000', 'lowerLimit': '-16.90', 'upperLimit': '-11.41'}, {'value': '-9.26', 'groupId': 'OG001', 'lowerLimit': '-12.01', 'upperLimit': '-6.50'}]}]}], 'analyses': [{'pValue': '0.0141', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Means Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-4.90', 'ciLowerLimit': '-8.80', 'ciUpperLimit': '-0.99', 'pValueComment': 'The comparison between treatments was conducted in a hierarchical order; consequently no adjustment of the significance level (5%) for multiplicity was needed.', 'estimateComment': 'Comment: The confidence interval is for the difference between treatments groups', 'groupDescription': 'Null hypotheses considered change in craving score means from pre-dose post-provocation at 50 seconds to be equal for the two treatment groups.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'ANCOVA model contains pre-provocation baseline, pre-dosing post-provocation craving score, and the terms treatment groups and center as fixed', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Pre-dosing post-provocation to 50 seconds', 'description': 'Participants completed a cigarette craving assessment consisting of the following five items: "I have a desire for a cigarette right now; If it were possible I would smoke right now; All I want right now is a cigarette; I have an urge for a cigarette; I crave a cigarette right now. All participants indicated craving intensity on a pre-drawn 100 millimeter (mm) Visual Analog Scale (VAS) ranging from 0 (disagree) to 100 (agree). The average of the scores over the five items was defined as craving score for each time point.', 'unitOfMeasure': 'mm', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who took at least one dose of medication and provided at least one valid craving assessment measurement on-treatment. Any participant with a missing response to any of the five craving assessment items was considered as a missing value and was imputed.'}, {'type': 'SECONDARY', 'title': 'The Change From Pre-dose Post-provocation in Craving Score at 3, 5, 7, 10, 15, 20, 25, and 30 Minutes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '161', 'groupId': 'OG000'}, {'value': '160', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Nicotine Mouth Film 2.5 mg', 'description': 'Participants received a single dose of 2.5 mg nicotine mouth film placed on the top of tongue and pressed to the roof of mouth until film dissolved (approximately 2 to 3 minutes).'}, {'id': 'OG001', 'title': 'Nicotine Lozenge 2 mg', 'description': 'Participants received a single dose of 2 mg nicotine lozenge to be placed into the mouth and periodically moved from one side of mouth to other, without swallowing until lozenge dissolved (approximately 20 - 30 minutes).'}], 'classes': [{'title': 'Difference in VAS Score at 3 Minutes', 'categories': [{'measurements': [{'value': '-27.02', 'groupId': 'OG000', 'lowerLimit': '-30.64', 'upperLimit': '-23.39'}, {'value': '-20.30', 'groupId': 'OG001', 'lowerLimit': '-23.93', 'upperLimit': '-16.67'}]}]}, {'title': 'Difference in VAS Score at 5 Minutes', 'categories': [{'measurements': [{'value': '-33.95', 'groupId': 'OG000', 'lowerLimit': '-37.88', 'upperLimit': '-30.02'}, {'value': '-28.33', 'groupId': 'OG001', 'lowerLimit': '-32.27', 'upperLimit': '-24.38'}]}]}, {'title': 'Difference in VAS Score at 7 Minutes', 'categories': [{'measurements': [{'value': '-39.13', 'groupId': 'OG000', 'lowerLimit': '-43.20', 'upperLimit': '-35.05'}, {'value': '-34.14', 'groupId': 'OG001', 'lowerLimit': '-38.23', 'upperLimit': '-30.05'}]}]}, {'title': 'Difference in VAS Score at 10 Minutes', 'categories': [{'measurements': [{'value': '-40.94', 'groupId': 'OG000', 'lowerLimit': '-45.08', 'upperLimit': '-36.80'}, {'value': '-39.16', 'groupId': 'OG001', 'lowerLimit': '-43.31', 'upperLimit': '-35.01'}]}]}, {'title': 'Difference in VAS Score at 15 Minutes', 'categories': [{'measurements': [{'value': '-42.19', 'groupId': 'OG000', 'lowerLimit': '-46.42', 'upperLimit': '-37.97'}, {'value': '-42.30', 'groupId': 'OG001', 'lowerLimit': '-46.53', 'upperLimit': '-38.06'}]}]}, {'title': 'Difference in VAS Score at 20 Minutes', 'categories': [{'measurements': [{'value': '-42.43', 'groupId': 'OG000', 'lowerLimit': '-46.77', 'upperLimit': '-38.09'}, {'value': '-45.23', 'groupId': 'OG001', 'lowerLimit': '-49.58', 'upperLimit': '-40.87'}]}]}, {'title': 'Difference in VAS Score at 25 Minutes', 'categories': [{'measurements': [{'value': '-43.16', 'groupId': 'OG000', 'lowerLimit': '-47.55', 'upperLimit': '-38.78'}, {'value': '-46.27', 'groupId': 'OG001', 'lowerLimit': '-50.67', 'upperLimit': '-41.88'}]}]}, {'title': 'Difference in VAS Score at 30 Minutes', 'categories': [{'measurements': [{'value': '-43.54', 'groupId': 'OG000', 'lowerLimit': '-48.11', 'upperLimit': '-38.97'}, {'value': '-47.48', 'groupId': 'OG001', 'lowerLimit': '-52.06', 'upperLimit': '-42.89'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Pre-dosing post-provocation to 3, 5, 7, 10, 15, 20, 25, and 30 minutes', 'description': 'Participants completed a cigarette craving assessment consisting of the following five items: "I have a desire for a cigarette right now; If it were possible I would smoke right now; All I want right now is a cigarette; I have an urge for a cigarette; I crave a cigarette right now. All participants indicated craving intensity on a pre-drawn 100 mm VAS ranging from 0 (disagree) to 100 (agree). The average of the scores over the five items was defined as the craving score for each time .', 'unitOfMeasure': 'mm', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Nicotine Mouth Film 2.5 mg', 'description': 'Participants received a single dose of 2.5 mg nicotine mouth film placed on the top of tongue and pressed to the roof of mouth until film dissolved (approximately 2 to 3 minutes).'}, {'id': 'FG001', 'title': 'Nicotine Lozenge 2 mg', 'description': 'Participants received a single dose of 2 mg nicotine lozenge to be placed into the mouth and periodically moved from one side of mouth to other, without swallowing until lozenge dissolved (approximately 20 to 30 minutes).'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '161'}, {'groupId': 'FG001', 'numSubjects': '161'}]}, {'type': 'Safety Population', 'achievements': [{'groupId': 'FG000', 'numSubjects': '161'}, {'comment': 'One subject randomized but did not receive the study treatment.', 'groupId': 'FG001', 'numSubjects': '160'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '161'}, {'groupId': 'FG001', 'numSubjects': '160'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'Participants were recruited at the clinical site.', 'preAssignmentDetails': 'A total of 386 participants were screened of which 322 subjects were randomized into the study. Sixty subjects were screen failures, Two subjects withdrew consent and an additional 2 subjects were not randomized due to other reasons.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '161', 'groupId': 'BG000'}, {'value': '160', 'groupId': 'BG001'}, {'value': '321', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Nicotine Mouth Film 2.5 mg', 'description': 'Participants received a single dose of 2.5 mg nicotine mouth film placed on the top of tongue and pressed to the roof of mouth until film dissolved (approximately 2 to 3 minutes).'}, {'id': 'BG001', 'title': 'Nicotine Lozenge 2 mg', 'description': 'Participants received a single dose of 2 mg nicotine lozenge to be placed into the mouth and periodically moved from one side of mouth to other, without swallowing until lozenge dissolved (approximately 20 - 30 minutes).'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '39.0', 'spread': '12.91', 'groupId': 'BG000'}, {'value': '39.8', 'spread': '12.64', 'groupId': 'BG001'}, {'value': '39.4', 'spread': '12.76', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '89', 'groupId': 'BG000'}, {'value': '73', 'groupId': 'BG001'}, {'value': '162', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '72', 'groupId': 'BG000'}, {'value': '87', 'groupId': 'BG001'}, {'value': '159', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 320}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-01', 'completionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-12-12', 'studyFirstSubmitDate': '2012-10-04', 'resultsFirstSubmitDate': '2013-12-12', 'studyFirstSubmitQcDate': '2012-10-04', 'lastUpdatePostDateStruct': {'date': '2014-01-30', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2013-12-12', 'studyFirstPostDateStruct': {'date': '2012-10-08', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-01-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The Change From Pre-dose Post-provocation in Craving Score at 50 Seconds', 'timeFrame': 'Pre-dosing post-provocation to 50 seconds', 'description': 'Participants completed a cigarette craving assessment consisting of the following five items: "I have a desire for a cigarette right now; If it were possible I would smoke right now; All I want right now is a cigarette; I have an urge for a cigarette; I crave a cigarette right now. All participants indicated craving intensity on a pre-drawn 100 millimeter (mm) Visual Analog Scale (VAS) ranging from 0 (disagree) to 100 (agree). The average of the scores over the five items was defined as craving score for each time point.'}], 'secondaryOutcomes': [{'measure': 'The Change From Pre-dose Post-provocation in Craving Score at 3, 5, 7, 10, 15, 20, 25, and 30 Minutes', 'timeFrame': 'Pre-dosing post-provocation to 3, 5, 7, 10, 15, 20, 25, and 30 minutes', 'description': 'Participants completed a cigarette craving assessment consisting of the following five items: "I have a desire for a cigarette right now; If it were possible I would smoke right now; All I want right now is a cigarette; I have an urge for a cigarette; I crave a cigarette right now. All participants indicated craving intensity on a pre-drawn 100 mm VAS ranging from 0 (disagree) to 100 (agree). The average of the scores over the five items was defined as the craving score for each time .'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['provoked craving'], 'conditions': ['Smoking Cessation']}, 'descriptionModule': {'briefSummary': 'Nicotine mouth film is a new dosage form of nicotine replacement therapy. The purpose of this study is to investigate the craving relief efficacy of nicotine mouth film by comparing mint nicotine mouth film to nicotine lozenge in light smokers using the provoked craving model. The cues used to provoke a craving episode will be the sight and smell of a lit cigarette and the manipulations required to light a cigarette. The smokers will be denied access to cigarettes for 4 hours prior to the provoked craving session in order to precipitate nicotine withdrawal and an increase level of cigarette craving.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* BMI within the range of 19-35 kg/m2;\n* Current cigarette smokers who have smoked regularly daily for at least a year,\n* Participants who smoke their first cigarette more than 30 minutes after waking up\n\nExclusion Criteria:\n\n* Known or suspected intolerance or hypersensitivity to nicotine (or closely related compounds) or any of the stated ingredients in formulation.\n* Any participant whose CO level rises during the sequestration period (i.e., the subject's two expired CO assessments immediately prior to the provoked craving paradigm are higher than the mean baseline CO assessment) and, in the opinion of the investigator, may have smoked during that time."}, 'identificationModule': {'nctId': 'NCT01702532', 'briefTitle': 'Nicotine Mouth Film for Craving Relief.', 'organization': {'class': 'INDUSTRY', 'fullName': 'GlaxoSmithKline'}, 'officialTitle': 'A Study to Evaluate Relief of Provoked Acute Craving by Nicotine Mouth Film and Nicotine Lozenge', 'orgStudyIdInfo': {'id': 'RH01589'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Nicotine Mouth Film', 'description': 'mint nicotine mouth film, buccal administration', 'interventionNames': ['Drug: Nicotine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Nicotine Lozenge', 'description': 'nicotine lozenge, buccal administration', 'interventionNames': ['Drug: Nicotine']}], 'interventions': [{'name': 'Nicotine', 'type': 'DRUG', 'description': 'Comparison of different dosage forms of nicotine', 'armGroupLabels': ['Nicotine Lozenge', 'Nicotine Mouth Film']}]}, 'contactsLocationsModule': {'locations': [{'zip': '91505', 'city': 'Burbank', 'state': 'California', 'country': 'United States', 'facility': 'Los Angeles Clinical Trials', 'geoPoint': {'lat': 34.18084, 'lon': -118.30897}}, {'zip': '40509', 'city': 'Lexington', 'state': 'Kentucky', 'country': 'United States', 'facility': 'Central Kentucky Research Associates, Inc.', 'geoPoint': {'lat': 37.98869, 'lon': -84.47772}}], 'overallOfficials': [{'name': 'GSK Clinical Trials', 'role': 'STUDY_DIRECTOR', 'affiliation': 'GlaxoSmithKline'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'GlaxoSmithKline', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}